CLINICAL ENGINEERING CHALLENGES Competition

Clinical engineering departments face the challenge of im­proving productivity and quality even though their resources are shrinking. The threat of downsizing, out-sourcing, and in­sourcing is very real. Competition with ISOs of the field ser­vice industry has intensified over the last 10 years, requiring in-house clinical engineering programs to organize them­selves as businesses, so as to reduce costs and to be competi­tive (17).

Justification

Clinical engineering departments must continually demon­strate their value to their institution. This is especially true as hospital staff changes. New people, both administrative and clinical, come on board who may be unfamiliar with the benefits of clinical engineering services. Continuous advertis­ing (brochures, newsletters, Web sites) and attendance at meetings is required to educate them as to clinical engi­neering’s vital role within the institution.

Remote Service

As health-care institutions merge and collaborate, and as ad­ditional satellite clinics are established to provide hospitals with clients, clinical engineering is faced with the logistics of providing services to remote locations.

Regulation

The FDA is considering extending good manufacturing prac­tices (GMP) rules and regulations to medical equipment re- furbishers, reconditioners, and servicers. This would require them to meet requirements similar to those of original medi­cal device manufacturers and remanufacturers. Clinical engi­neering departments as equipment servicers may be im­pacted (44).

Home Safety

Clinical engineers may have to become more involved in safety issues related to the increased use of medical equip­ment for home care and how to provide such services. For example, home dialysis requires preliminary inspection of the patient’s home site to ensure adequate electricity and water and then periodic visits for PM and repair.

Year 2000 (Y2K) Compliance Healthcare devices and sys­tems (information systems, medical equipment, and general hospital systems) that use software or contain microproces­sors may be prone to the Year 2000 problem. If so, as the date changes from Dec. 31, 1999 to Jan. 1, 2000 they may incor­rectly represent the year 2000 as 1900 (or some other date). Some equipment might operate erroneously, others not at all. Such failure could affect patient safety, produce incorrect printouts and archiving, and increase risk to the institution. Clinical engineering involvement and allocation of resources are required to ensure equipment compliance (45).

Seeking New Opportunities

Clinical engineering departments must be flexible, adapting to the times and conditions of the ever-changing health-care institutions they serve. The feasibility of providing additional services for X-ray and ionizing radiation equipment, comput­ers, computer networks, patient information systems, tele­communications, and nurse call systems should be investi­gated. Although with proper training, clinical engineering staff should be able to repair these items just as they repair other sophisticated equipment falling within their domain, a realistic approach must be taken with consideration given to available resources (i. e., funds for training and FTE alloca­tion), as well as the political realities of ‘‘turf’’ within their particular institutions. Clinical engineers should also strive to become more involved in technology assessment issues for new technologies including telemedicine, robotics, PACS, and wireless LAN, helping to determine the value of introducing them into their institution.

Such flexibility will ensure that the relatively new profes­sion of clinical engineering will mature and continue to pro­vide value to the institutions it serves, as it moves forward into the 21st century.

ACKNOWLEDGMENTS

Photographs were taken by Ernest Cuni, Biomedical Commu­nication, SUNY HSCB, 1998.

I wish to thank all members of SMIC’s staff, both past and present, with whom I have worked over the past 20 years. It is through our daily interaction that the concepts presented have been better defined. In particular, thanks to John Czap, Luis Cornejo, Leonard Klebanov, and Marcia Wilkow. Also, M. K. Venugopal who understood and valued SMIC’s services. Thanks also to Barbara Donohue and Kelly Galanopoulos who offered specific suggestions to enrich the content.

Clinical Engineering Oversight

Oversight Function. Clinical engineering provides an im­portant oversight function whose primary purpose is to re­duce risk of injury to patients and staff as well as liability to the institution for which they work. While carrying out their mandate duties of the clinical engineering department can sometimes cause client irritation. As an example, review of equipment purchase requisitions, questioning clinical users about preferred equipment choices, coupled with the bid pro­cess, and need to provide justification to purchase other than the low bidder’s equipment lengthen the equipment ordering process. On occasion, clinical engineering management may even disallow the purchase or use of devices found to be un­safe due to extremely poor workmanship, inherent design de­fects, or dangerous failure modes. Acceptance testing, which disallows immediate clinical usage of equipment, tends to frustrate clinicians anxious to use the equipment and causes them to question the need for acceptance testing (only want­ing electrical safety tests to be run). They sometimes prema­turely schedule patients, in-service education, and removal of old equipment upon equipment arrival into the institution, leaving little if any time for testing. These issues make it crit­ical that clinical engineers understand that as they strive to satisfy regulatory requirements, safety requirements, and ethical considerations, they must also strive to streamline their operation to provide services as quickly as possible, so as not to alienate their clients. It is important to demonstrate to clients through timely feedback and education that clinical engineering is a vital resource and not an impediment.

Dangers in Bypassing Oversight Function. There are times even with hospital policies in place, that clinical engineering is not consulted for what is felt to be expediency. The result is often increased cost, delays, and increased risk to the insti­tution.

Not involving clinical engineering during the prepurchase evaluation process is counterproductive. This is particularly true while planning for new clinical areas or renovating ex­isting ones. Having to open newly constructed walls to add electrical outlets or to provide additional reinforcement to allow required medical equipment to be mounted, all of which should have been planned for prior to construction, is both costly and time-consuming.

Problems also arise when equipment is ordered, and physi­cal plant conditions are not suitable for its operation. For ex­ample, a type of endoscopic sterilizer requires clean water, and a specified minimum water pressure (often not found in certain urban areas especially during summer months). With­out these environmental conditions being met, the unit will not function and additional external filtration (which quickly clogs) does not remedy the situation. Studying specifications and having clinical engineering personnel interact with facili­ties engineering staff prior to such equipment being ordered reduces the chance of such expensive nonfunctioning installa­tions.

Clinical engineering involvement in purchase requisition review reduces the possibility that incorrect equipment is or­dered. Ordering nonstandard equipment requires additional user training and increases the chance of patient injury due to user equipment unfamiliarity. This also compounds main­tenance requirements and the types of accessory supplies re­quired.

Clinical engineering acceptance testing prevents unsafe equipment with defects being put into service and eliminates premature payment authorization that results in loss of lever­age in defect problem resolution. Also, this assures the equip­ment is entered into the equipment inventory, PM scheduling is done, eliminating problems during regulatory inspections, such as untested devices turning up just prior to inspection when limited time is available to process them. To minimize problems it is important that clinical engineering work closely with the purchasing and expenditures processing depart­ments to assure that medical equipment falling within the mandate of the clinical engineering department is not ordered or paid for without clinical engineering approval.

Computerized Maintenance Management Systems

Computerized maintenance management systems (CMMS) software is a powerful technology management tool used to collect, store, and analyze data (Fig. 12). To utilize such pro­grams, some clinical engineering departments rely on their institution’s mainframe computer or a file server and local area network maintained by the information services depart­ment, while others maintain their own file server and local area network taking on the responsibility for data backup and integrity. Some use internally developed CMMS software, while others purchase commercially available packages. CMMS systems generate reports relating to all aspects of the operation of a clinical engineering department, including equipment management. Technology assessment software is also available.

Functions of CMMS are as follows (30):

Maintain an equipment inventory and nomenclature system

Select and schedule PM (based on risk factors)

Track work including repair, user in-service training, con­struction and research projects

Prioritize work load

Track equipment and vendor services provided under war­ranty or service contract

Track loaner and leased equipment

Identify medical equipment needing replacement due to constant breakdown and large downtime Select new equipment for purchase based on past perfor­mance and cost effectiveness of similar equipment Detect trends that pinpoint the need for additional user training due to operator error, NFF, equipment damage, or abuse

Detect trends that pinpoint the need for additional service training such as repeat repairs Generate work-completed reports for customers, including lists of equipment that cannot be located (CNL)

Bill customers Maintain parts inventories Generate reports for hospital administration Analyze clinical engineering performance (financial, qual­ity, and productivity)

Assist in long-range forecasting

Benchmarking

Purpose and Methodology. A management tool for continu­ous quality improvement, benchmarking allows comparison of an organization to other similar organizations so that better techniques can be ascertained and adopted to improve perfor­mance and customer service.

Benchmarking can be informal or formal. Informal bench­marking consists of gathering information about similar insti­tutions by contacting colleagues and comparing clinical engi­neering parameters and functions. Formal benchmarking requires filling in a detailed questionnaire and submitting it to an outside organization for analysis. Such analysis is pro­vided as a service to university hospitals throughout the coun­try that are members of the University Healthcare Consor­tium (42). This benchmarking process allows member institutions to compare their operations. Institutions that submit data have agreed that all other member institutions may gain access to it for purposes of improvement.

Caution in Use. Benchmarking can be helpful (43) and the possibility of improvement exists. However, the results must be properly used. It is important when comparing institutions not only to consider the number of FTE, which may not be an absolute number as it may be based on overtime or be nor­malized (i. e., to a 40 h week), but also to compare fully the services each clinical engineering department provides. This is critical if such data are used to make operational decisions that relate to staff size. Analysis may well show that those chosen as ‘‘better performers” do not provide services that are vital to another institution. It is also important to consider the acquisition cost of equipment being maintained. Some de­partments are required to handle more sophisticated equip­ment that is both time consuming and costly to repair, thus increasing FTE requirements.

Finally, some point out that comparison of in-house clinical engineering departments to each other, using the ratio of number of engineers per bed, is a wasted effort as their real competitor is not each other, but outside service providers, who could replace them both (17).

MANAGEMENT Health-Care Technology Management

Health-care technology includes all of the components needed to diagnose and treat human disease (illness). This includes medical equipment (devices, systems, and software), supplies, pharmaceuticals, biotechnologies, and medical and surgical procedures as well as the health-care facilities (hospitals, etc.) that are used to house the patients and medical equipment (23). Health-care technology management deals with all of the health-care technology components. Included in health­care technology management is equipment management, technology planning, and technology assessment.

Equipment Management

Definition and Purpose. Equipment management deals spe­cifically with the medical equipment and is the cornerstone of an effective clinical engineering program. An equipment man­agement program that encompasses the more traditional clin­ical engineering duties (23) controls the risks associated with using medical equipment for patient care by detecting and correcting hazards before injuries can occur. Proper equip­ment maintenance (a core component of equipment manage­ment) maximizes the useful life of medical equipment and minimizes its lifetime cost.

Although equipment management includes the core ser­vices of equipment maintenance (PM and repair), it goes be­yond these services to include most phases of equipment life­span. It is involved with equipment acquisition, which includes equipment assessment, equipment specification, RFQ generation, and vendor selection. It encompasses instal­lation planning, acceptance testing, user in-service education, selection of service provider, product recalls and alerts, and incident investigation, as well as PM and repair. It also in­cludes equipment replacement analysis, removal, and sal­vage (30).

Better equipment management decisions save money. They reduce equipment downtime, eliminate the need to pay for emergency equipment rentals, and allow better equipment replacement decisions to be made that consider past equip­ment failures and expenses in addition to equipment capabili­ties. Equipment and consumable standardization is also en­couraged (3).

An equipment management program must be compliant with JCAHO guidelines and regulatory requirements such as those of the Department of Health (DOH), College of Ameri­can Pathologists (CAP), and American Association of Blood Banks (AABB).

Centralization. Ideally, a centralized equipment manage­ment program capable of handling all patient-care equipment (including anesthesiology, clinical laboratories, and respira­tory care) is desired. More sophisticated institutions are plac­ing all medical equipment maintenance funding in the clinical engineering budget. Consolidation makes economic sense as it allows an institution to more easily track its true equipment maintenance costs. Cost-effective service contracts can be ne­gotiated and unnecessary ones eliminated. Interface between the institution and equipment vendors and manufacturers be­comes simpler (30). Record-keeping is standardized, demon­strating to JCAHO that a uniform level of service for all medi­cal devices exists as well as a centralized data repository. Centralization also makes it clearer to an institutions’ staff that the clinical engineering department should be consulted for all equipment-related services.

AAMI Recommended Practices. AAMI is presently finalizing the recommended practice “Required characteristics for a med­ical equipment management program” (41), that reflects ex­isting good practice, addresses program structure, required documentation generation, staffing, and resource allocation. It acknowledges that many clinical engineering programs al­ready exceed these minimum requirements. AAMI’s goal is that others strive to exceed them as well. This document should help newly formed, smaller clinical engineering de­partments (and health-care facility managers) to define what is expected as a starting point better.

Technology Planning

Technology planning supplements an equipment manage­ment program. It helps to further ensure that appropriate equipment that is cost-effective, efficacious, and safe is avail­able, allowing the institution to meet quality patient-care de­mands. Technology planning includes greater clinical engi­neering involvement in the determination of equipment replacement needs, equipment acquisition, facility planning and design (to ensure equipment needs are accommodated), as well as continuous technology assessment (23).

Technology planning allows an institution to remain com­petitive by choosing new technologies that complement ex­isting hospital services and present strategic advantage to the institution against competitors. It also reduces liability risk for the hospital and clinical staff by helping to identify legal standards of care requirements requiring purchase of new or additional equipment. As example, the requirement that pulse oximetry (SAO2) monitoring, end-tidal CO2 monitoring, or both be provided during general anesthesia (3).

Technology Assessment

Technology assessment (a component of technology planning) analyzes all of the consequences of introducing a new technol­ogy [i. e., bone marrow transplant or picture archiving and communications systems (PACS)] into a health-care institu­tion, prior to any equipment being purchased. Analysis in­cludes consideration of the equipment required, techniques to be used, FTE personnel requirements, size and makeup of pa­tient base, community impact, and financial considerations.

Figure 12. Computerized Maintenance Man­agement System. Computerized Maintenance Management Systems (CMMS) are used by clinical engineers to track their workload. This includes repairs, preventive mainte­nance scheduling, and other requests for engi­neering assistance. CMMS also maintain an equipment inventory and maintenance his­tory information. The two clinical engineering supervisors are querying the system to obtain lists of equipment of specific clinical areas so that they can plan and assign workloads for the staff.

The goal of the analysis is to reduce the possibility of purchas­ing expensive and inappropriate equipment that cannot gen­erate income for the institution. By assisting in this task, the clinical engineering staff’s awareness of new and emerging technologies aids in more wisely allocating capital resources

(3).

Repair (Unscheduled Maintenance)

Figure 11. Repair, infant warmer. Repair of medical instrumentation requires electrical troubleshooting skills. Here, an infant warmer is being evaluated using a multime­ter to assure that the thermostat controls will function properly so as to prevent harm to the infants.

Purpose and Methodology. The purpose of repair is to re­store equipment so it meets original equipment manufacturerspecifications. This is accomplished by determining the mal­function and fixing it so as to retain the efficacy and safety of the device (Fig. 11).

Prior to doing repair a determination should be made as to whether the device is under warranty or service contract. If so, the appropriate service provider should be contacted. If under contract, clinical engineering screening may be re­quired to verify that a problem does exist and warrants a ven­dor service call. Determination should be made as to whether it is cost-effective to repair the device or if it should be retired from service (due to lack of parts availability or expense) and a replacement purchased.

Depending upon severity repairs can be done either in the clinical engineering laboratories or on-site in the user facility. In general, unless one has a good reason not to, original OEM parts should be used. During repair, built-in diagnostics are helpful, and the instrument operator and service manuals from the clinical engineering technical library, as well as the devices history file, prove invaluable.

On-site emergency support during the day allows the engi­neer to witness the problem first-hand. On-call/recall for emergencies during off-hours allows instrumentation problem troubleshooting by phone. This coupled with substitution of spare equipment often eliminates the need for return to the institution.

Work reports are filled out in a similar manner as for ac­ceptance test and PM. Included should be the problem, steps taken to resolve the problem, parts used, and pertinent test data. These reports keyed to the instrument’s unique identi­fication number are filed in the instrument’s history folder, and suitable computerized data entry is made.

Parts and Service Manuals. A problem faced when repairing medical devices is that manufacturers are sometimes unwill­ing to provide necessary replacement parts, insisting that more costly field replaceable units be purchased instead. They argue that proper repair requires automatic test equipment verification that is only available at the factory, and that they will be liable should the device malfunction after such repair

(40) . Also, although required under the FDA Federal Medical Device Amendments of 1976 to provide service literature con­taining installation, operation, and maintenance information, some manufacturers are unwilling to provide service manuals with proper schematics, arguing that their technology is pro­prietary, or they require a nondisclosure document be signed. Prior to signing any such agreement it is best to check with the institution’s legal counsel to determine the ramifications of doing so. It must be stressed that the time to resolve the manuals issue is during pre-purchase requisition review. Not only is repair impacted by not having operator and service manuals, but equipment acceptance testing is as well, as equipment specifications and detailed test information is to be found there. Some clinical engineering departments do not even schedule acceptance test unless these manuals are first received.

Equipment Retirement

Equipment is retired from service when it:

Is obsolete and can no longer be cost-effectively repaired due to lack of parts or expense.

Becomes unreliable and prone to constant failure.

Poses a hazard to patient or user.

Is replaced by newer technologies.

Is no longer the choice of the clinical staff (3).

Depending upon the institution and the equipment condition it could be:

Cannibalized for parts.

Traded in for a newer device.

Sold.

Offered to a sister institution.

Donated to a school.

In any case, appropriate disposal procedures must be fol­lowed, including notifying property control and making en­tries into the CMMS and equipment history files.